Recombinant adeno-associated virus (rAAV) vectors have become essential in gene therapy for delivering therapeutic genes effectively. However, the challenge of separating empty capsids from genome-containing particles remains a significant hurdle, impacting product purity, safety, and overall efficacy. Traditional methods, such as density gradient ultracentrifugation, have been widely used but present scalability and consistency issues. Recent developments in anion exchange chromatography (AEX) using weak organic acids provide an innovative solution, allowing efficient separation and enrichment of genome-containing capsids without the limitations of gradient elution. This paper discusses the successful application and scalability of AEX for rAAV purification, offering a promising pathway for large-scale gene therapy manufacturing.
